National Pre-Authorisation Schemes to Ensure Public Health 

– Scientific Uncertainty, National Policy Choices, and the Risk of Bias

Scientific uncertainty is clearly a prominent hurdle in public health policy and the policy choices made to tackle this uncertainty are largely left to the Member States. Indeed, the Court of Justice of the EU has long since held that the health and the life of humans rank first among the interests that Member States can legitimately pursue – even if they restrict the market freedoms in doing so – and that, therefore, very considerable powers are left to Member States in the field of public health. Over the years, Member States have often turned to the regulatory tool of pre-authorisation schemes to protect national public health, especially in the face of scientific uncertainty. Through such schemes, everything from pesticides to food additives have been restricted from entering national markets. But how can the EU be sure that the inherent discretion of such authorisation schemes does not give effect to national bias? This article will explore how the EU has developed various ‘objectivity safeguards’, mainly through case-law, in order to contain the risk of such bias. In the end, even if considerable policy powers are left to Member States in the field of public health, a pre-authorisation scheme would not be considered as a justified restriction to free movement, unless the national system provides sufficient safeguards.